Low; BirthweightDAHLIANCT04954807
Indonesia After Discharge LBW Infant HMF Supplementation Study
A study testing human milk fortified in people with Low; Birthweight and Breast Feeding, Exclusive, run by Universitas Indonesia at 4 sites in Indonesia.
Trial summary
Low birth weight (LBW) infant (1800-2449 gram) will be given the new human milk fortifier (HMF) which contains protein, lipid, carbohydrate and micronutrients after discharge. Human Milk Fortifier or placebo (carbohydrate only with similar calorie content) will be provided until 3 months of age. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Low; Birthweight, Breast Feeding, Exclusive, Gestational Age and Weight Conditions
- What is being tested?
- human milk fortified
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 4 sitesIndonesia
- Study dates
- 8 Dec 2020to 25 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Low birth weight infants (1800-2499 g) with oral feeding
- Exclusively breastfed or predominantly breastfed (consuming term infant formula less than 50 ml/Kg BW/day) at discharge
- Discharge from the hospital before 2 weeks of age and maximal age of enrolment is 14 days old
- Live in greater Jakarta
- Parents agree in writing to study participation and indicate their intention to follow study procedures.
Who cannot join
- Any subject who has major congenital anomaly or any other disorder(s) that infers with normal feeding, growth, and neurodevelopment.
- Participating in another intervention trial
Trial locations and contacts
4 sites in 1 country.
Indonesia4 sites
Hermina Hospital
Bekasi, West Java
Budi Kemuliaan Hospital
Jakarta, Central Jakarta, 10110
Pasarebo Regional Hospital
Jakarta, 13760
Koja District Hospital
Jakarta
About this study
Official title: Growth and Body Composition of Low Birth Weight Infants Supplemented With Human Milk Fortifier After Discharge: A Double-Blind Randomized Clinical Trial
Low birth weight (LBW) infant (1800-2449 gram) will be given the new human milk fortifier (HMF) which contains protein, lipid, carbohydrate and micronutrients after discharge. Human Milk Fortifier or placebo (carbohydrate only with similar calorie content) will be provided until 3 months of age. The investigators want to evaluate if the addition of HMF to mother's milk while breastfeeding LBW infants after discharge influences growth and body composition up to 3 months of age.
Read the detailed description
This is a prospective two arms parallel double-blind randomized clinical trial in LBW infants. Clinically healthy LBW infants discharge on oral feeding of human milk before 2 weeks of age (< 15 days old) will be invited to participate in the study. Exclusively or predominantly breastfed infants will be encourage to use finger feeding as method of supplementation, but mothers can choose their own preferences if they wish to do so.
After signing the informed consent by parent, subject will be randomized to one of four group. Randomization list were prepare by one investigator who do not involve in recruitment, outcome measures and statistical analysis. Study product will be labeled as A, B, C D in similar tin. Only manufacturer know the content of these tins and the code will be revealed after statistical analysis completed. Parents will be given this 200 g tin of study product and ask to return the tin after 14 days of opening. Unblinded assistant will weight the tin before and after opening to estimate the HMF intake for 14 days.
This study will be conducted in several hospitals in Greater Jakarta.
Adherence to study protocol will be encouraged during face to face session initially in dispensing study product and subsequent visits (visit 1 at one-month-old, visit 2 at two months old). These sessions will include the reminder of the importance of following study protocol, breastfeeding support if needed and discussion about difficulties that arise. The investigators will also remind mothers via text to fill in three days diary of intake one week before each visit.
- Being tested
- human milk fortified, placebo
- Keywords
- Low Birth Weight, Breast Feeding, Body Mass Index, Human Milk Fortifier, Small Gestational Age
- Medical subject headings
- Birth Weight, Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
human milk fortifiedDietary supplement
HMF will be given 6 scoops a day
placeboDietary supplement
Placebo will be given six scoops a day
| Study group | Role | What they receive |
|---|---|---|
| Human Milk Fortifier | Active comparator | human milk fortifier which contains protein, lipid, carbohydrate and micronutrients Receives: Dietary Supplement: human milk fortified |
| placebo | Placebo comparator | Placebo is made of polysaccharides (0.9 g/1 g placebo) and maltose (0.1 g/1 g placebo) and minerals. Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gaining weight
Gain in weight (g/kg initial weight \& difference) between study enrolment and three months of age
Measured: three months of age
Secondary outcomes (11)
Average weight gain
Average daily weight gain (g/kg/day) from enrolment to at three months of age
Measured: enrollment to three months of age
Gaining length
Gain in length (mm initial length \& difference) from study enrolment to the age of 3 months
Measured: Three months of age
Head circumference
Gain in head circumference (mm initial head circumference \& difference) from study enrolment to the age of 3 months
Measured: Three months of age
Weight for age
Difference of weight for age (Z score) from study enrolment to the age of 3 months
Measured: Three months of age
Body fat percentage
Difference in body fat percentage between groups
Measured: Three months of age
Stool consistency
Median type of stools according to Diapered Infant stool chart between groups
Measured: enrollment to three months of age
Stool frequency
average stool frequency per day between groups
Measured: enrollment to three months of age
Vomit
Number of subjects who reported to have vomit between groups
Measured: enrollment to three months of age
Bloating
Number of subjects who reported to experience bloating between groups
Measured: enrollment to three months of age
Fever
Number of subjects who reported to experience fever between groups
Measured: enrollment to three months of age
Rehospitalization
Number of subjects who reported being hospitalized between groups
Measured: enrollment to three months of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start8 Dec 2020
- Primary completion23 Feb 2022
- Study completion25 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low; BirthweightStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects in the intervention group will be given the new human milk fortifier which contains protein, lipid, carbohydrate and micronutrients while the control group will receive placebo (polysaccharides 0.9 g/1 g placebo and maltose 0.1 g/1 g placebo and minerals). Assuming the average weight is 2 Kg, 6 scoops (@1.0 g) will provide 1.95 g protein and 25.5 Kcal in the intervention group while 6 scoops of 1.1 g in the control group will provide 26.4 Kcal with no protein. Three times a day, supplementation with 2.0 gram (intervention group) or 2.2 gram (control group) of study product will be provided, regardless of the actual weight of the subject. Both groups will receive iron supplementation 2 drops daily (5 mg elemental iron in forms of Fe III hydroxide polymaltose complex) since 2 month old as a routine supplementation recommended by Indonesian Pediatrics Society.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Responsible party
- Principal investigator, yoga devaera, Universitas Indonesia
- Investigators
- Yoga Devaera, MD, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04954807
- Sponsor's protocol ID
- 20-02-0127
- Acronym
- DAHLIA
- Status last verified
- Mar 2022
- First submitted
- 14 Jun 2021
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol will be published in a scientific journal. Others data will be available upon request to principle investigator.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth and Body Composition of Low Birth Weight Infants Supplemented With Human Milk Fortifier After Discharge: A Double-Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04954807
- Acronym / sponsor ID
- DAHLIA / 20-02-0127
- Keywords
- Low Birth Weight, Breast Feeding, Body Mass Index, Human Milk Fortifier, Small Gestational Age
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- Ludwig-Maximilians - University of Munich
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 23 Feb 2022 (actual)
- Study completion
- 25 Feb 2022 (actual)
- First posted
- 8 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low birth weight (LBW) infant (1800-2449 gram) will be given the new human milk fortifier (HMF) which contains protein, lipid, carbohydrate and micronutrients after discharge. Human Milk Fortifier or placebo (carbohydrate only with similar calorie content) will be provided until 3 months of age. The investigators want to evaluate if the addition of HMF to mother's milk while breastfeeding LBW infants after discharge influences growth and body composition up to 3 months of age.
Detailed description
This is a prospective two arms parallel double-blind randomized clinical trial in LBW infants. Clinically healthy LBW infants discharge on oral feeding of human milk before 2 weeks of age (< 15 days old) will be invited to participate in the study. Exclusively or predominantly breastfed infants will be encourage to use finger feeding as method of supplementation, but mothers can choose their own preferences if they wish to do so.
After signing the informed consent by parent, subject will be randomized to one of four group. Randomization list were prepare by one investigator who do not involve in recruitment, outcome measures and statistical analysis. Study product will be labeled as A, B, C D in similar tin. Only manufacturer know the content of these tins and the code will be revealed after statistical analysis completed. Parents will be given this 200 g tin of study product and ask to return the tin after 14 days of opening. Unblinded assistant will weight the tin before and after opening to estimate the HMF intake for 14 days.
This study will be conducted in several hospitals in Greater Jakarta.
Adherence to study protocol will be encouraged during face to face session initially in dispensing study product and subsequent visits (visit 1 at one-month-old, visit 2 at two months old). These sessions will include the reminder of the importance of following study protocol, breastfeeding support if needed and discussion about difficulties that arise. The investigators will also remind mothers via text to fill in three days diary of intake one week before each visit.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Subjects in the intervention group will be given the new human milk fortifier which contains protein, lipid, carbohydrate and micronutrients while the control group will receive placebo (polysaccharides 0.9 g/1 g placebo and maltose 0.1 g/1 g placebo and minerals). Assuming the average weight is 2 Kg, 6 scoops (@1.0 g) will provide 1.95 g protein and 25.5 Kcal in the intervention group while 6 scoops of 1.1 g in the control group will provide 26.4 Kcal with no protein. Three times a day, supplementation with 2.0 gram (intervention group) or 2.2 gram (control group) of study product will be provided, regardless of the actual weight of the subject. Both groups will receive iron supplementation 2 drops daily (5 mg elemental iron in forms of Fe III hydroxide polymaltose complex) since 2 month old as a routine supplementation recommended by Indonesian Pediatrics Society.
| Arm | Type | Receives |
|---|---|---|
| Human Milk Fortifier | Active comparator | Dietary Supplement: human milk fortifiedhuman milk fortifier which contains protein, lipid, carbohydrate and micronutrients |
| placebo | Placebo comparator | Dietary Supplement: placeboPlacebo is made of polysaccharides (0.9 g/1 g placebo) and maltose (0.1 g/1 g placebo) and minerals. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Low birth weight infants (1800-2499 g) with oral feeding
- Exclusively breastfed or predominantly breastfed (consuming term infant formula less than 50 ml/Kg BW/day) at discharge
- Discharge from the hospital before 2 weeks of age and maximal age of enrolment is 14 days old
- Live in greater Jakarta
- Parents agree in writing to study participation and indicate their intention to follow study procedures.
Key exclusion criteria (2 listed)
- Any subject who has major congenital anomaly or any other disorder(s) that infers with normal feeding, growth, and neurodevelopment.
- Participating in another intervention trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| human milk fortifiedHMF will be given 6 scoops a day | Dietary supplement | Human Milk Fortifier |
| placeboPlacebo will be given six scoops a day | Dietary supplement | placebo |
Primary outcome
Gaining weight
Time frame: three months of age
Gain in weight (g/kg initial weight \& difference) between study enrolment and three months of age
11 secondary outcomes
Average weight gain
Time frame: enrollment to three months of age
Gaining length
Time frame: Three months of age
Head circumference
Time frame: Three months of age
Weight for age
Time frame: Three months of age
Body fat percentage
Time frame: Three months of age
Stool consistency
Time frame: enrollment to three months of age
Stool frequency
Time frame: enrollment to three months of age
Vomit
Time frame: enrollment to three months of age
Bloating
Time frame: enrollment to three months of age
Fever
Time frame: enrollment to three months of age
Rehospitalization
Time frame: enrollment to three months of age
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Individual participant dataSharing planned: Yes. Study protocol will be published in a scientific journal. Others data will be available upon request to principle investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yoga Devaera, MD principal investigator
Universitas Indonesia
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing human milk fortified in people with Low; Birthweight and Breast Feeding, Exclusive, run by Universitas Indonesia at 4 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gaining weight (time frame: three months of age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022; AzTrials last refreshed its copy on 4 Nov 2026.